A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

Completed · Phase 2 · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.

Key facts

Study ID

NCT01605825

Run by

Acorda Therapeutics

People needed

83

Starts

2012-05-01

Expected to finish

2013-03-01

Last updated by the study team

2016-01-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by the Investigator with supportive prior imaging findings (MRI/ CT scan)
• ≥ 6 months post-stroke
• Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive
• Stable concomitant medication therapy regimen within 4 weeks of screening visit

You may not qualify if…

• History of seizures, except simple febrile seizures
• Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
• Botulinum toxin use within 2 months prior to the Screening Visit
• Orthopedic surgical procedures in any of the extremities within the past 6 months
• Diagnosis of multiple sclerosis

Where it is running

• Acorda Site #011 — Birmingham, Alabama, United States
• Acorda Site #018 — La Jolla, California, United States
• Acorda Site #016 — Newport Beach, California, United States
• Acorda Site #006 — Fairfield, Connecticut, United States
• Acorda Site #002 — Atlantis, Florida, United States
• Acorda Site #015 — Fort Lauderdale, Florida, United States
• Acorda Site #003 — Decatur, Georgia, United States
• Acorda Site #021 — Lexington, Kentucky, United States
• Acorda Site #009 — Boston, Massachusetts, United States
• Acorda Site #017 — Saginaw, Michigan, United States
• Acorda Site #020 — Great Falls, Montana, United States
• Acorda Site #023 — Reno, Nevada, United States
• Acorda Site #022 — New Brunswick, New Jersey, United States
• Acorda Site #019 — Buffalo, New York, United States
• Acorda Site #007 — West Haverstraw, New York, United States
• Acorda Site #004 — White Plains, New York, United States
• Acorda Site #013 — Charlotte, North Carolina, United States
• Acorda Site #001 — Philadelphia, Pennsylvania, United States
• Acorda Site #008 — Norfolk, Virginia, United States
• Acorda Site #010 — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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